We have a video-based lecture next that's actually going to be presented by three speakers, inviting Dr. Joanna Law from Virginia Mason Medical Center in Seattle, and also Dr. Andrew Storm from Mayo Clinic in Rochester. And they will be joined by Dr. Swati Bhava, who's already on our panel. Thank you so much. Thank you. We'd like to thank the organizers and the ASGE for inviting us, Drs. Bhava, Dr. Storm, and I are unable to make it, but there we go, have the following disclosures. Today, we hope to, by the end of this talk, have reviewed anatomy and our approach to hyaluronobstruction. We're going to do this as a case review with some videos and engage our panel with regards to criticism or discussion, at least it should be a healthy discussion about how we've approached some of these. Quite nerve-wracking, especially looking at this panel sitting here. And then also talk about emerging endoscopic techniques and devices being used for hyalurobstruction. So we're going to primarily focus on malignant hyalurobstructions, but obviously there's non-malignant. The most common, though, for the malignant hyalurobstructions are going to be, our approach would be intrinsic versus extrinsic. In general, the five-year survival is usually less than 10% with greater than 70% presenting as non-resectable. And these are the diagnostic criteria for hyaluronobstruction. So the appearance of a malignant stricture on imaging, and at least one of the following, biopsy or cytology positive for malignancy, CE199 tumor marker that's elevated greater than 1,000 in the context of someone without cholangitis, or aneuploidy by FISH. There are emerging different sampling techniques that are arising, including next-gen sequencing, which are still being validated. The most important approach to malignant hyalurobstruction, though, is a multidisciplinary consensus. So having, you know, your surgeons, your radiologists, your pathologists, your oncologists, at least get involved in terms of discussing how to approach a patient and discuss tissue acquisition in addition to drainage. With the goals of being, is there an obvious mass lesion, is there any evidence of intra or extra ductal, what is the extent of your intraductal involvement, what is the relationship relative to vascular structures, any evidence of lymph nodes, and in this image you can see a tiny little lymph node right there. In addition to also evaluating for atrophy and assessing liver volumes is a roadmap for drainage. I'm just going to put this up here just to remind us in terms of how we approach when we see someone with malignant hyalurobstruction, making sure we talk about the bismuth classification and it's in terms of your endoscopic reporting or what you perceive. So then when you come to a patient with malignant hyalurobstruction, you do ask yourself, is this resectable? If the answer is yes, then will ERCP impact surgery? If the ERCP does not impact surgery, you really should not do the procedure just to what Dr. Almanzar has said. We really have to identify which patients are the appropriate patients undergoing the procedure. If the answer is yes in terms of assisting the surgeons in terms of planning, then your ERCP should, you should also consider cholangioscopy at the same time to not only determine the extent of your disease, but also with the intent of draining greater than 50% of viable non-atrophic liver. And then if you're not sure whether or not this patient is resectable, then you would probably proceed with the ERCP to determine the extent of disease. If this person is totally not resectable, then obviously an ERCP with brushings and drainage should be indicated. So in our first case, this was a 72-year-old male we recently saw at our institution who basically had a past medical history of alcoholism, or alcohol use disorder, sorry, and hypertension. He presented with painless Shondes. He endorsed drinking about 24 to 30 beers a day and really had no other significant medical history. His outside labs showed a bilirubin of 12.6 with normal less than 1.2 milligrams per deciliter. On transfer, the CT report had suggested a possible pancreatic head mass. This is his CT scan, basically showing as we scroll through, you can see what appears to be crowding of the bile ducts with dilation in the left side, and it's suggestive of an atrophic left lobe of the liver. You can also, as we continue to scroll, you'll start to appreciate some lymph nodes throughout the abdomen, and then what appears to possibly be maybe, oops, sorry, a mass in the hylum. As we, so let me just, next one, it's not going to let me go, but you can appreciate some lymph nodes as well. There's one right there. And then so we, unfortunately when we inherited him or had him brought over, he already had a PTBD in to his right side, and so we rendezvoused ourselves up, and we were quite lucky in that sense. So the rendezvous and ERCP portion basically with knowing that the wire is in the right liver, we were able to obtain a occlusion cholangiogram that basically demonstrated this hylar stricture in the common hepatic duct, and then we never really pacified the left side. The patient then ultimately got brushings, which then confirmed a diagnosis of cholangiocarcinoma and had a one-sided, right-sided stent in place. So based on the ASGE guidelines, they suggest that in potentially resectable malignant hylar restriction, the routine use of PTBD is not recommended as a first-line drainage option, and at the index ERCP, quite often we have no definitive answers on pathology, resectability, or optimal drainage strategy. I think in this patient who ended up getting, you know, by the time we got tissue diagnosis, his bilirubin came down quite nicely down into the one range. He actually became a surgical candidate, and it was, you know, we had already endoscopically ultrasounded all those lymph nodes, which were all negative and suggestive, more consistent with his cirrhosis, for which you can get adenopathy. He actually just had his resection, and has an R0 resection for a 1.2-sonometer mass, and is actually doing well. Any thoughts in terms of how that patient was managed, Dr. Sullen? Just want to highlight, if everyone looks at the November issue of GIE, there's a really nice editorial from Rich Kizerik talking about kind of controversies in hylar tumor management. And I think what I'll try to do through a couple more cases is to highlight the controversy that came up even in writing this guideline. So the ASGE group who wrote the guideline, a lot of us are co-authors presenting today, and it just shows that there is controversy. What type of stent should we use? What portions of the liver should we drain? And I totally agree with your management here, which was we avoided an atrophic segment. We did our best to drain the largest, healthiest portion of the liver, and we bridged someone ultimately to a surgery by not choosing a metal stent. So I think with very different situations, we would have made very different choices. But in this case, I can't argue with your management. That's great. Any other thoughts down the table? Super. So we'll continue with some cases, again, trying to show off some of the conclusions that we reached in writing these guidelines. So this second case, again, like Joe, picked cases that have been within the last six months in my practice. So this was a gentleman who I met who had metastatic gastric cancer. Again, we're not looking at the black box of indeterminate strictures, which is one of the huge remaining problems in advanced endoscopy and GI. This is someone who has a diagnosis. So this gentleman had, you can even appreciate here on his CT scan, thickening of the stomach wall. So he had lunitis plastica. The entire stomach, basically, was cancer. And this extended through to the hilum of the liver and even down into the duodenum. So he had duodenal obstruction as well. But when he presented to us, his bilirubin was 14. He had a previously placed plastic stent. Again, this was placed 10 days previously in my practice by an expert endoscopist using my favorite stent for hilar obstruction, which is the Jolin wedge stent. This is a multi-hold stent, which is placed up into the liver. It allows drainage of various, you know, you don't jail any parts of the system. It allows drainage throughout the liver. It was designed for the pancreas, but works really well with both eight and a half and 10 French options. But this stent had been placed. Maybe as a contrast to Joanna's case, we saw that there was just one stent placed. And then in an effort, and because it was such a challenging cannulation, you can see reflecting back to our pep talk, a pancreatic duct stent had been placed as well. So there was no improvement in bilirubin despite this stent being placed, again, very expertly. It extends, you can see from the cross here. It extends a bit further up than you would think. And in fact, here during that ERCP, you can see it probably lays within a very dilated left intraepatic ductal system. Again, duodenal obstruction was present. So this ERCP was performed almost blindly using a clip to guess where the papilla was, really just using fluoroscopy to guide cannulation. So this is a, you know, final exam kind of ERCP for our fellows. And then the patient, when he saw me, now 10 days after his last ERCP, he said, look, man, this is going to be my last ERCP. So whatever you do today, I want this to be the end. And that's going to influence the choices that I made during that ERCP procedure. So what I'll show you here are the tricks that I've learned through all of my mentors in how to manage this very complicated hyler plus essentially the entire bile duct obstruction. So I was able to achieve, I did over the, through the stent wire guided cannulation. So I found that Jolin stent, cannulated that, placed a four millimeter biliary balloon across that wire inside the biliary stent and pulled it out over the wire so I didn't lose cannulation in what I knew would be a blind, an endoscopically blind situation. That gave us access up into the diet, very dilated biliary tree you can see here. And what I did is first laid a bare metal stent from the hylum to this right side. And my particular choice, again, there will be controversy. The entire panel will have differences of opinions on this. I really like the Cooke Zilver stent because this allows us to work through these kind of zigzag lightning bolt shaped interstices. I think it works well for this Y paradigm that I'm going to show you today. There's also wonderful opportunities for side by side stenting with smaller six and eight millimeter intraductal stents. And again, just to highlight another controversy in ERCP, there are thoughts about whether or not one should traverse the papilla with a stent. So should this be purely intraductal stenting? That is probably superior for many patients. Again, for this gentleman who I knew had obstruction all the way down to the duodenum, I needed to lay overlapping bare metal stents. So we'll continue the video here. Again, a stent up into the right side and then a second stent bridging us all the way down into the duodenum. Here's the real challenge of this procedure and where it takes a little bit of a leap of faith. So I know that his left intraepatic system is large dilated and not atrophic. So I need to drain that area. It's been drained previously and I'm not addressing it yet. If you look over here at the fluoroscopy time, this is going to be probably the longest ERCP of my year this year. This is at 45 minutes of fluoroscopy time. So a significant effort in order to achieve cannulation of this left-sided duct. So what I didn't show is I went through three different wires. And for fellows in the audience who hear their ERCP docs talking wires, this is part of why you do a fellowship is to learn all these different tools available to you. But what's ultimately successful here is a 0.018 inch. That's basically the diameter of a thick human hair wire that is angled on its tip. And that's allowing me to work through the interstices of this stent and find our way towards this left-sided duct. Even with that wire, I was having some difficulty. And so you saw a blast of contrast. I call that surfing the wire. So I'm pushing fluid up above the wire, trying to find that opening. I could see that I was probably a little below. And then here, ultimately, we all celebrate in the room because we've achieved access to that area. Now here's the next hard part. You can see here I'm trying to introduce a balloon catheter through the interstices of the stent. And it's not permitting me to do so. So here's where we'll use a variety of different tools, either balloon dilators, so hendriate dilation catheters, other stiff catheters, to push open the interstices of this stent to fully deploy it and allow us to work through the side holes of the stent and enter this left-sided system. Here you can see after some maneuvers, we got the balloon in. Now why did contrast fill up above? This is because if you've ever played with these stents, they're quite sharp. So the balloon burst. The good news there is your tech, if they work with you often, they know that they can keep spinning and keep putting pressure on that balloon. Even after it bursts, we're able to get a good dilation of that area. And again, you can see that the caliber in that area has improved significantly. So even though we burst our balloon, no problem. This has opened up the interstices enough now for us to introduce a 7 French biliary occlusion balloon catheter. This is my test device. So if I'm able to get this through and fill out a nice cholangiogram on the left, I know then I'll be able to introduce my stent deployment catheter. Here I'm going to put a stiffer wire, so this is a wire that's going to allow me to pull some traction and work as an anchor over which to deploy that second stent. And so this is again just a kind of a classic example in my practice of performing a Y stent technique for a patient who says I will not have another ERCP and I want something that's going to be durable. So I believe and I think our guidelines suggest that in a patient who's appropriate for bare metal stenting, for palliative stenting, using this bare metal paradigm can be can be helpful, is probably more durable. Just as some case follow-up. So the ASGE guideline statement, in patients with unresectable malignant hiler obstruction with poor life expectancy and limited interventions, we suggest metal stents. For transplant candidates, for patients in whom the drainage strategy is not clear, we suggest plastic stents. Again this is the kind of compromise that the group here came in making these recommendations. So these are things that will not be board exam questions because they are still very controversial. Whenever you see that we're using the word suggest, that usually means there remains controversy in in the folks writing those guidelines. With bilateral obstruction, we suggest bilateral stents. So in conclusion for that patient, the bilirubin came down from 14 to 1.8. He had a great response, no further stenting needed, and he's now four months from that ERCP, has not required a second procedure, which is great, great for my patient. So the third case, we'll talk about when traditional stents fail. This is a 68 year old woman with unresectable metastatic intra-hepatic cholangiocarcinoma, bilirubin of 11. She had an atrophic right liver lobe with cancer all throughout, presenting with cholangitis two weeks after upgrading from a plastic bilateral stenting paradigm to a metal stent, which really just extends to her left main hepatic duct. And a dilated left segment on her presentation was concerning as the source of her cholangitis. So here you can see, again, these nice plastic stents have been placed. Because of the nature of the CT scan, you don't see that these do extend nicely up into the area. But again, this is the system that I believe is probably infected. This was the placement of that left intra-hepatic duct, uncovered metal stent, intraductal stent, a nice example of that, where the stent actually terminates well above the papilla. And this is providing drainage to that left side. So that left stent was placed, again, by one of my colleagues expertly previously, but she represented with cholangitis. And it looks like from that CT scan that there are very, there's a segment of the left side of the liver, which has been jailed or is not draining well with that uncovered metal stent. And so I believe her cholangitis is in these dilated ducts. And this is going to highlight a new treatment paradigm, which is emerging, I think becoming more and more popular, certainly in our system and others, using endoscopic ultrasound to guide drainage of this area. So we'll see here, it's sort of a chip shot. These dilated ducts are only about two centimeters away from the gastric wall. So here we've advanced a 19 gauge needle through the left lobe of the liver, and we're getting a very nice cholangiogram showing that even though there's a metal stent up here, there's really no drainage of this inferior segment of the left lobe of the liver. There's a plastic stent still in sight you over on the right. And so here we're advancing a wire, we're able to get wire access through this area and through the uncovered metal stent which was previously placed. We got our nice cholangiogram injecting contrast through this area. And then the challenge here is to just remain as still as possible to keep yourself right on that track that you've created with your 19 gauge needle. And then to try to introduce your next tool. So like with working through the side holes of the metal stent, this is the challenging part here. Will we be able to dilate our tract in order to place a stent? Fortunately we have a new cystotome, so an electrocautery assisted cystotome from Taiwu. They're able to now use EUS guidance to cut our way using electrosurgical energy, cut our way through the tract. So you can see here bubbles because I'm using a needle knife to open this tract. And this gives us a very nice track through the liver. We were not able to previously advance our balloon. This is going to allow that balloon catheter to fly right over our guide wire. And so here you can see again that tract we're leaking bile and the balloon catheter is then advanced through. And here you can see the balloon filling. I like to do this entire procedure under EUS guidance. This is not an EUS associated procedure. This is very much an EUS guided procedure. And here's that balloon dilation into the that inferior left hepatic duct that was dilated. You can see after achieving that balloon dilation now to six millimeters we'll be able to place any size stent we'd like. This is the Gore viable stent which is everyone's choice currently. Fortunately I see the future including some very precisely hepatic gastrostomy devised devices and stents that are going to be even better than what we have now allowing others to perform this procedure regularly. And you can see here just air in that stent showing us that that we've created that hepatic gastrostomy tract very nicely. This is on follow-up in healing. So we do do this procedure in patients with ascites. I'll try and find the area where there's the least amount of ascites to allow that tract to heal. This is two months later just showing that that stent is still in situ. That's a good palliative option for her. And I'll ask the AV team one more time please to advance me a slide. So in conclusion her bilirubin from 11 to 1.2. Cholangitis resolved and she was able to go home to home hospice three months later. So state of the evidence here, EUS hepatic gastrostomy. If you could give me another advancement please. For hyaluronic laryngeal carcinoma in 34 patients. ERCP failure, duodenal stricture, and rheumatoid gastric bypass anatomy the most common reasons. Technical success was quite high. Clinical success more than half. Adverse events in 26%. Of course this is a procedure that everyone is learning now. No one is really a seasoned expert in this procedure yet. And I think there will be more to come including dedicated devices. I'll now hand off to complete the presentation kind of looking towards the future. Some new techniques available to my colleague Dr. Pawa from Wake Forest. That was excellent Andy and Joe. I'll see what I can do. So what I'm going to talk about for the next few minutes is the role of RFA or radiofrequency ablation in cholangiocarcinoma and mostly in extra hepatic cholangiocarcinoma. The intra hepatic being a completely different disease process. So we're going to start off with a case. It's a 66 year old man with metastatic biliary or gallbladder adenocarcinoma who presented with recurrent biliary obstruction despite the bilateral uncovered metal stance that you can see on both sides. So you can see that the left side fills well but the right side has a high grade stricture which extends into the right hepatic duct because of tumor ingrowth from from the tumor itself. Next slide please. Can you go to the next slide please? So what was decided was that we were going to perform radiofrequency ablation to see if we could clear the obstructed stent of the tumor in growth but initially started off with a balloon dilation to enable easy passage of the eight French RFA catheter. So that's what you're seeing over here. Once the balloon dilation is achieved you can see the RFA catheter which is introduced. Two treatments were done at 10 watts for 90 seconds with an interval of 60 seconds in between and then a cholangiogram was obtained which shows improved right hepatic duct caliber and a balloon suite was performed to remove the debris from the coagulum because of the RFA. Next slide please. So let's briefly talk about radiofrequency ablation. It basically involves a bipolar catheter which coupled with high frequency alternating current raises the temperature of the target tissue to induce thermal necrosis and cell death. So unlike PDT which has fallen out of favor this actually works with direct tissue contact so the duration of the contact the distance between the electrodes and the wattage used will determine the heat that will be delivered to the tissue which can actually be substantial sometimes and I'll show you some pictures. The therapeutic effect of RFA is supposed to be because of direct ablation of the contacted tissue so it kills by contact locally but also it's postulated that indirectly it releases immunogenic cell components and it might actually work by changing the milieu of the tumor so that it might respond better to chemotherapy and maybe slow the progression of disease. So there are two RFA catheters that are available. The first one is an eight French Habib catheter which most of us use and I've had experience with at our center. It has a five millimeter leading tip and then it has the two electrodes which are eight millimeters with eight millimeters apart so a total burn if you were to position them under fluoroscopy in the stricture would be about 24 to 25 millimeters in length and the ablation zone is about 3 to 4 millimeters deep. On the other hand this is the newer RFA catheter from a Korean company called the Eldra RFA catheter. We don't we don't have it in our unit but we're trying to get this one. It's available in the US now. It's customizable so the good thing is it has different sizes so you can treat small areas, wider areas, and especially if you're going intrahepatic this might be the better catheter to have. We don't have any head-to-head comparisons of both as well but energy is delivered at a set wattage and it has an advantage that it has a temperature probe at the distal end of the device which measures the temperature and regulates the energy output. So this is what you're seeing on the, I'm gonna stop this for a second, but we'll just talk about how this is done and then I'll show you a video of the cholangiocarcinoma first, then the RFA that's applied, and then the char that you see post the RFA. The RFA catheter initially is passed over the guide wire and across the malignant stricture and fluoroscopy is used to center the bipolar rings of the RFA. So here you're actually seeing the mass-like, frond-like cholangiocarcinoma in the bittery tree. We go ahead and we apply the RFA into this area. Again, if it's an intrahepatic duct, it's 7 watts. If it's extra hepatic, it's 10 watts. And again, there is no standardized procedure of how much you want to do. I think some centers do one application of 90 seconds, some do two applications of 90 seconds with a 60 second interval. And the worry always is that this can be a full thickness burn and can lead to complications from there. So it's always good to leave a stent after you've done this. And so to my right, you're gonna see now that we are actually, I don't know, okay, it's working now. So you can actually see that we've actually done the RFA and the char that's the burn that you see throughout the segment, which can be deep and full thickness. And so you want to take a balloon, sweep the coagulum, and leave a stent in there to prevent strictures down the line. So the adverse events following endobiliary RFA are almost comparable to the adverse events with just biliary stenting alone, except that the RFA group in this particular meta-analysis had more post-procedure abdominal pain. But otherwise, they didn't see any significant differences. But the data is all over the place, which I didn't choose to show. But you know, there's a regularity of data. Data might be more on bismuth 1 and 2, which are better cancers to handle than 3 and 4. And some studies have shown benefit with stent patency and overall survival, and some have not. So I would like to conclude by saying that RFA is safe, feasible, approved for prolonged stent patency, and shown to improve survival in a few studies. RFA is as effective as PDT, with fewer side effects, requiring less logistical or infrastructural effort. But standardized treatment protocols for RFA with regards to energy settings, number, and frequency of sessions need to be studied. Thank you.

hyaluronic acid obstruction

endoscopic techniques

malignant obstructions

diagnostic criteria

multidisciplinary consensus

radiofrequency ablation

cholangiocarcinoma